Job description Posted 14 December 2021

Regulatory Affairs - Medical Devices


Pay rate up to £41 per hour via Umbrella inside IR35

12 month contract

Job Purpose

The purpose of this role is to provide regulatory management, governance and expertise to one category, sub-category, brand or a portfolio of products such that our products are successfully introduced or maintained Globally. The individual will build a network of collaborative relationships within the sub-category and LOC/Region and ensure all regulatory requirements are met for both innovation and existing products according to GSK Values. An individual may also manage a small team for which they will set a compelling vision and deliver against the sub-category strategy and mission. The role may require the individual to provide specialist regulatory advice across the Category and Function.

Role Responsibilities

·     Acts as a Business Partner and provides regulatory advice across a brand or subset of products on aspects of drug / cosmetic / devices / food and supplements (dependent on category) development and regulatory requirements as appropriate.

·     Develops novel regulatory strategies and influences approaches within Project Teams in order to secure competitive approvals and speed to market in conjunction with LOC/Region regulatory teams.

·     Communicates effectively within the function at all levels and within cross-functional Project Teams.

·     May supervise or mentor other team members.

·     Plans, prepares and delivers high-quality regulatory files to agreed timelines.

·     May lead non-product related activities within the function and input cross functionally, in order to direct new policy or pioneer new processes or improvements to GSK's competitive advantage.

·     May act as GSK representative to external groups on specific task forces within their field of expertise.

·     Support the development of the strongest claims possible aligned to consumer insight and within the regulations, ensuring risks are appropriately addressed and communicated within the CAP meetings and tools.

·     In conjunction with the category regulatory CMC lead, ensure support for the full life cycle of products, including: maintenance activities; Design to Value, complexity reduction, value engineering initiatives; change controls, etc. with supply chain and technical excellence.

·     Ensures compliance of their actions by adhering to global, regional and local processes, policies, SOPs and working instructions.


Candidate Requirements

·     Regulatory professional at this level must be skilled in scientific interpretation/evaluation/communication of technical information

·     Experience with Product lifecycle support ensuring compliance and requiring regulatory strategy and filing of submissions at a global level.

·     Oversight of the defined products requires a strong background in medicines, devices, cosmetics or dietary supplements.